drugset / Trial / NCT02013050

A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

NCT02013050 ↗

Phase 2 Completed 111 enrolled Soligenix
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Timeline

Start
2013-12
Primary completion
2015-12
Completion
2016-09

Outcome

Met primary endpoint

release “Phase 2 clinical trial in which SGX942 (dusquetide) demonstrated a statistically significant reduction in the median duration of severe oral mucositis” soligenix.com ↗

release “In this clinical trial that enrolled 111 patients, SGX942 (1.5 mg/kg dusquetide) demonstrated a positive, clinically meaningful reduction in the median duration” soligenix.com ↗

release “Soligenix has reported positive Phase 2 results with SGX942 in the treatment of oral mucositis in head and neck cancer (HNC) patients.” soligenix.com ↗

release “SGX942 at a dose of 1.5 mg/kg successfully reduced the median duration of severe oral mucositis by 50% in all patients” soligenix.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dusquetide Protein / enzyme biologic 1.5 mg/kg —
Subject Dusquetide Protein / enzyme biologic 3 mg/kg —
Subject Dusquetide Protein / enzyme biologic 6 mg/kg —